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A Pilot Study of the Efficacy and Program Cost-effectiveness of Prevention Plus for Childhood Obesity

The University of Tennessee, Knoxville logo

The University of Tennessee, Knoxville

Status

Completed

Conditions

Obesity

Treatments

Behavioral: Growth Monitoring plus Family-based Behavioral Counseling
Behavioral: growth monitoring

Study type

Interventional

Funder types

Other

Identifiers

NCT01358448
UT8433B

Details and patient eligibility

About

In 2007 the Expert Committee published recommendations on the prevention and treatment of childhood obesity. These recommendations outlined four interventions intended for advancement based on the child's age, body mass index (BMI), and response to treatment. The initial stage, Prevention Plus, is to be implemented in the primary care setting and focuses on primary care providers monitoring growth monthly and delivering intervention messages that target dietary and leisure-time behaviors that most contribute to energy imbalance in children. Little research has evaluated the efficacy of these recommendations. Thus the primary goal of the proposed pilot study is to test the feasibility of the Prevention Plus stage for treating childhood overweight and obesity in a primary care setting. As the cost of interventions is a large barrier to the translation of evidence-based research into primary care settings, a second goal of the project is to evaluate program cost-effectiveness.

Enrollment

22 patients

Sex

All

Ages

4 to 8 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • between 4 to 8 years of age at the start of the intervention
  • overweight or obese (≥85th BMI-for-age percentile)
  • have no medical conditions that effect growth, intake or physical activity (e.g., Prader Willi Syndrome, type 2 diabetes, etc.)
  • not currently participating in a weight loss program and/or taking weight loss medication
  • have a primary caretaker willing to participate in the research study, receive monthly newsletters and be randomized to one of the three conditions
  • caretaker must be able to read, speak and understand English and the child speak English
  • have transportation to their child's primary care provider office
  • family does not plan to move out of the area before March 2012

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

22 participants in 3 patient groups

Newsletter
No Intervention group
Growth Monitoring
Experimental group
Treatment:
Behavioral: growth monitoring
Growth Monitoring plus Family-based Behavioral Counseling
Experimental group
Treatment:
Behavioral: Growth Monitoring plus Family-based Behavioral Counseling

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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